Evaluation of p16/K67 dual stained slides as a biomarker for cervical cancer.
National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB), plans to procure, on a sole source basis, evaluation of p16/K67 dual stained slides as a biomarker for cervical cancer from Ventana Medical Systems of 1910 East Innovation Park Drive Tucson, AZ 85755. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitionist. The North American Industry Classification System code is 541990 and the business size standard is $15.0M. Despite Human Papillomavirus (HPV) vaccines, screening will remain central for decades to control cervical cancer. Recently, HPV testing alone or with cytology was introduced in the U.S. as an alternative to cytology screening. However, most HPV infections are harmless and additional tests are required to identify women at highest cancer risk. With tee options for primary screening, and without clear strategies for triage of screen-positive women, there is great confusion about the best approach. Also, increasing HPV vaccination coverage will lead to lower disease prevalence, and force new screening approaches. A cytological p16 assay has been previously evaluated for triage of HPV-positive women, but it required morphological evaluation of p16-stained cells. Concurrent p16 and Ki-67 staining on cytological slides eliminates the need for morphological evaluation. The p16/Ki-67 dual stain has shown promise for detection of cervical precancer. NCI is evaluating p16/Ki-67 dual stain cytology as part of a larger study evaluating many biomarkers for cervical cancer screening. Ventana is the only known provider of p16/ki67 staining. The assay is protected by patents (U.S. Patents US 6,709,832 & US 7,425,617) and there are no other known sources providing a p16/Ki-67 assay. Ventana is therefore the only known source that can fulfill NCI's requirements. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM ET, on May 20, 2019. All responses and questions must be via email to Miguel Diaz, Contracting Officer at miguel.diaz@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification tough SAM.GOV and have Representations and Certifications filled out. Reference: 75N91019Q00059 on all correspondence. 75N91019Q00059 Department of Health and Human Services National Institutes of Health
5/6/19, 11:12 AM